The results of four multicenter, randomized, placebo-controlled, parallel group studies of the efficacy of becaplermin gel are reviewed here. The four studies included a total of 922 patients, all of whom received a standardized regimen of good ulcer care. Patients were randomized to receive placebo gel, 30 or 100 μg/g becaplermin gel, or good ulcer care alone.

In Studies 1 and 2, the incidence of complete healing was significantly higher in patients receiving becaplermin gel (30 μg/g, Study 1; 100 μg/g, Study 2) compared with that in patients receiving placebo gel. In Study 3, which was not powered for statistical analysis, the incidence of complete healing in patients treated with 100 μg/g becaplermin gel was approximately twice that of patients treated with good ulcer care alone. In Study 4, there was no significant difference in the incidence of complete healing in patients treated with becaplermin gel versus good ulcer care alone.